Companion diagnostics (CDx) have emerged as indispensable tools in the field of personalized medicine, facilitating the identification of patient-specific treatments and improving clinical outcomes. However, the development and deployment of CDx tests require strict adherence to quality and regulatory standards across international markets. This presentation provides a concise overview of the quality and regulatory requirements, including biostatistical challenges, for CDx in the United States, Europe, and Japan.
Understanding the intricacies of CDx quality and regulatory requirements across these regions is crucial for stakeholders involved in CDx development, from manufacturers to healthcare providers. This presentation serves as a starting point for navigating the complex landscape of CDx regulation in several key regions and fostering innovation while ensuring patient safety and product effectiveness on a global scale.
Registration Fees & Deadlines
Member $0 | Nonmember $25 | Students $0
Objectives
- A basic understanding of Companion Diagnostic Compliance and Regulatory Requirements for the US, Europe, and Japan
- Biostatistical considerations when dealing with challenges from bridging study analyses
Who Should Attend?
- Pharma and medical device company
- Quality personnel and management
- Compliance personnel and management
- Regulatory personnel and management
Agenda
- In-Person starting at 5:30PM EST:
Barnes & Thornburg LLP
11 S Meridian St
Indianapolis, IN 46204
- Virtual starting at 6:00 PM EST
Speakers
John Lockwood, Sr. Director - US Head of MedTech at PharmaLex
Lauren Frazee, Manager, Data Science at PharmaLex
Questions
Contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org